CE Mark for DFINE’s STAR™ Tumor Ablation System

Following FDA clearance back in 2010, Californian spinal technology company DFINE, Inc., has now received CE Mark approval for its STAR™ Tumor Ablation System for treatment of painful metastatic spinal tumors. The company officially launched the system in Europe at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress last month.

Background

There are more than 3.4 million new cancer diagnoses each year in Europe alone. When cancer is not found early, it can spread or metastasize to other parts of the body. A spinal tumor is a growth of cells in or around the vertebra near the spinal cord. It is estimated that 30 – 40 percent of cancer patients will likely develop metastatic spinal tumors.

Patients suffering from painful spinal tumors have limited options. Indeed many are in excruciating pain and unable to perform activities of daily living.

DFINE dedicates iteslf to developing minimally invasive therapies that relieve pain and improving the quality of life for patients suffering from vertebral pathologies.

One such therapy is targeted RF ablation (t-RFA) with the STAR Tumor Ablation System, which was developed specifically for metastatic vertebral body tumors. With STAR, the physician can target precisely where the device’s energy is delivered to heat and destroy the tumor, providing rapid and lasting pain relief in a single treatment.

The STAR System received 510k clearance in the United States in August 2010 and according to DFINE has demonstrated strong clinical outcomes at centers across the country.

CIRSE, the world’s largest and most prestigious conference in the field of minimally invasive image-guided therapies, took place in Barcelona, Spain Sept. 14 – 19, 2013.

Company comments

“We are very excited to bring this new treatment modality to Europe so that the hundreds of thousands of patients suffering from painful spinal tumors can receive the rapid pain relief that patients here in the U.S. have experienced. This represents a significant milestone for the company,” said Greg Barrett, Chief Executive Officer of DFINE.